MAUDE Adverse Event Report: EBI, LLC / ZIMMER BIOMET BONE HEALING TECHNOLOGIES BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number 1067721

Device Problems Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 05/01/2020

Event Type  Injury  

Event Description

Caller called to report that when she has positioned the strap around her calf the pain she felt awoke her from her sleep and she could not walk due to pain below her knee.She also, reports that the patches that attached to the electrodes don't stick and she has received replacement patches from the patient care advocate (b)(6).Reporter states that she was "advised by them to report to the fda the problems that she has had with this device".The reporter also request that if anyone needs to call her including the manufacturer that they only call her after 1:00 pm pacific time.

Event Description

Add'l info received from reporter on 11/14/2020 for mw5096248: as requested, the night i strapped transmitter to just above calf (to avoid sliding down), i awakened to excruciating pain just below knee on side of left leg, and couldn't even walk on it that day since.Same has happened for an hour or two, about every 10 days or so.

Event Description

Additional information received for report mw5096248 on 12/16/2020; re: update form sent this week.Re: device (access # mw5096248) and drug item on az board (case# (b)(4)).

• Brand Name: BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
• Type of Device: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): EBI, LLC / ZIMMER BIOMET BONE HEALING TECHNOLOGIES
• MDR Report Key: 10448746
• MDR Text Key: 204452997
• Report Number: MW5096248
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1067721
• Device Catalogue Number: 1067721
• Device Lot Number: 1946
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 64 YR